Different Ozone Concentrations for Knee Osteoarthritis

NCT07662512 | Completed

• 1 other identifier: E-71522473-050.04-372963-174
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

Knee osteoarthritis is a common condition that causes pain, stiffness, and difficulty with daily activities. Ozone injection therapy is a minimally invasive treatment that has been increasingly used to relieve symptoms in people with knee osteoarthritis. However, it is not clear whether different ozone concentrations produce different treatment outcomes. In this study, we compared the effects of two commonly used ozone concentrations (15 μg/mL and 25 μg/mL) in patients with knee osteoarthritis. A total of 159 patients received intra-articular ozone injections and were followed for 3 months. Pain, physical function, and quality of life were assessed before treatment and at 1 and 3 months after the injections.

Conditions

Knee Osteoarthristis; Gonarthrosis

Keywords

knee osteoarthritis; intra-articular injection; ozone therapy; ozone concentration

Outcome Measures

Primary Outcomes (1)

• Numeric rating scale (NRS)

  The NRS is a widely utilised tool for assessing and tracking pain severity. The rating scale consists of 11 points, where 0 signifies the absence of pain and 10 denotes the most excruciating pain imaginable. The patient is instructed to assess their pain on this scale from 0 to 10.

  prior to the procedure and at 1 and 3 months post-procedure.

Secondary Outcomes (1)

• Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  prior to the procedure and at 1 and 3 months post-procedure.

Other Outcomes (1)

• Short Form-12 (SF-12)

  prior to the procedure and at 1 and 3 months post-procedure.

Study Arms (2)

15 μg/ml-10 ml ozone (Group A)

ACTIVE COMPARATOR

Other: ozone injection

25 μg/ml-10 ml ozone (Group B)

ACTIVE COMPARATOR

Other: ozone injection

Interventions

ozone injection OTHER

Ozone (O2-O3) therapy is widely used in clinical practice as an alternative medical approach in the treatment of musculoskeletal diseases. Many recent studies have reported that intra-articular ozone implementation has a positive impact on knee osteoarthritis. Most available studies have focused on the comparison of ozone therapy with other intra-articular injections. However, the influence of the concentration and/or volume of the ozone used during injection on treatment outcomes has been omitted. The concentration of ozone administered into the joint varies, typically ranging from 15 to 30 μg/ml in these studies; however, there is no consensus regarding the appropriate dosage to be used. Based on this gap in the literature, we aimed to compare pain, functional status and quality of life among patients treated with different concentrations of intra-articular ozone therapy.

15 μg/ml-10 ml ozone (Group A); 25 μg/ml-10 ml ozone (Group B)

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 50-85 years with a diagnosis of primary knee osteoarthritis according to the American College of Rheumatology \[12\] criteria, symptomatic knee with KL \[13\] grades II, III and IV, who underwent intra-articular ozone treatment.

You may not qualify if:

• Patients with a history of any intra-articular injection within 3 months before the first ozone injection, a history of previous knee surgery, a diagnosis of malignancy, missing follow-up parameters, bilateral intra-articular knee ozone injection, a secondary knee osteoarthritis diagnosis (trauma, inflammatory joint disease, etc.), patients without demographic and clinical data, or direct radiographs.

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University

Adapazarı, Sakarya, 54010, Turkey (Türkiye)

Location

Related Publications (27)

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MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Ozone

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Oxygen; Gases; Inorganic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patients who underwent intra-articular knee ozone injection were examined and divided into two groups as 15 μg/ml (Group A) and 25 μg/ml ozone (Group B).

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 23, 2026
• Study Start: May 2, 2023
• Primary Completion: May 2, 2024
• Study Completion: June 3, 2024
• Last Updated: June 23, 2026

Record last verified: 2026-06

Locations

TU (1)